Senior PK/PD Modeling Programmer (NONMEM)

Cytel; United States; Remote; USD 110,000 - 170,000; Full time

Job summary

Cytel Inc. is seeking a Senior Statistical Programmer to work embedded with a pharmaceutical client, providing PK/PD modeling and data analysis support across studies and e-submission preparation.

The role requires extensive SAS programming with clinical trial data, NONMEM experience, and strong CDISC SDTM/ADaM knowledge. You will lead data-related tasks, QC work, and contribute to submission documents in a global CPP team.

Qualifications

• Bachelor's degree in statistics, computer science, mathematics or equivalent.
• 6+ years of SAS programming with clinical trial data; 4+ years with a master's degree.
• Experience leading studies or multiple projects preferred.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience with CDISC SDTM/ADaM standards.
• Experience supporting submissions with define.xml and related docs.

Responsibilities

• Prepare programming scripts (SAS, R) to generate NONMEM analysis inputs for PK/PD.
• QC NONMEM input datasets and document QC findings and actions.
• Assemble e-submission packages with input data, controls and define files.
• Guide junior CPP team members on DataFlow and data collection tools processes.
• Collaborate with DM, BAN/BDS, EPOD and vendors to meet CPP data needs.
• Revise SOPs, templates and training materials for CPP processes.

Skills

SAS programming

R programming

PK/PD modeling

NONMEM

Data management

CDISC SDTM/ADaM

QC & validation

E-submission

Education

Bachelor's degree in Statistics/CS/Math

Master's degree or higher preferred

Tools

SAS

R

NONMEM

Define.xml

Job description

Cytel Inc. is seeking a Senior Statistical Programmer to work embedded with a pharmaceutical client, providing PK/PD modeling and data analysis support across studies and e-submission preparation.

The role requires extensive SAS programming with clinical trial data, NONMEM experience, and strong CDISC SDTM/ADaM knowledge. You will lead data-related tasks, QC work, and contribute to submission documents in a global CPP team.